The Multistrain Probiotic OMNi-BiOTiC® Active for Upper Respiratory Tract Infections in Older People
- Conditions
- Acute Upper Respiratory Tract Infection
- Interventions
- Other: PlaceboDietary Supplement: OMNi-BiOTiC® Active
- Registration Number
- NCT05879393
- Lead Sponsor
- University Maribor
- Brief Summary
The goal of this randomised controlled trial is to determine the effect of consuming a multistrain probiotic OMNi-BiOTiC® Active to shorten the incidence and duration of acute upper respiratory tract infections (URTIs) in older people. The main questions it aims to answer is:
* Is the multistrain probiotic OMNi-BiOTiC® Active effective in reducing the incidence of URTIs in older people?
* Is the multistrain probiotic OMNi-BiOTiC® Active effective in reducing the duration of URTIs in older people?
* Is the multistrain probiotic OMNiBiOTiC® Active effective in changing selected immunological blood parameters in older people? Researchers will compare the probiotic group and the placebo group to see if the incidence or duration of URTIs are significant among the groups.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 95
- 65 years or older at the signing of the written consent form
- ability of participant to eat independently
- ability of participant to adhere to all procedures of the clinical study
- participants experienced an exacerbation of an existing chronic disease
- participants experienced an exacerbation of metabolic diseases,
- participants with mental incapacity to understand instructions
- participants were prescribed long-term usage of antibiotics.
- participants that changed their eating habits or consumed any probiotics 14 days
- participants with markedly abnormal results of blood tests were excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo rice starch, maltodextrin, plant protein, potassium chloride, magnesium sulphate, manganese sulphate Multistrain Probiotic OMNi-BiOTiC® Active OMNi-BiOTiC® Active Lacticaseibacillus casei W56, Lactobacillus acidophilus W37, Ligilactobacillus salivarius W24, Levilactobacillus brevis W63, Lactococcus lactis W58, Lactococcus lactis W19, Bifidobacterium animalis subsp. lactis W52, Bifidobacterium longum subsp. longum W108, Bifidobacterium breve W25, Bifidobacterium animalis subsp. lactis W51 and Bifidobacterium bifidum W23. Additional ingredients:corn starch, maltodextrin, plant protein, potassium chloride, magnesium sulphate, manganese sulphate and vanillin
- Primary Outcome Measures
Name Time Method Incidence of URTI 12 weeks supplementation Comparison of the incidence of acute upper respiratory tract infections among older people in both arms
- Secondary Outcome Measures
Name Time Method Duration of URTI 12 weeks supplementation Comparison of the duration of acute upper respiratory tract infections among older people in both arms via the use of a questionnaire
Changes in concentration of leukocytes, neutrophils segm., lymphocytes, monocytes, eosinophils, basophils in serum 12 weeks supplementation Differences in the serum concentration of leukocytes, neutrophils segm., lymphocytes, monocytes, eosinophils, basophils, measured in 10x9/L of the participants in the first winter season as a change from baseline to 12 weeks upon administration of probiotics compared to placebo
Changes in concentration of Immunoglobulin A (IgA) in serum 12 weeks supplementation Differences in the serum concentration of immunoglobulin A (IgA), measured in g/L of the participants in the first winter season as a change from baseline to 12 weeks upon administration of probiotics compared to placebo
Trial Locations
- Locations (1)
University of Maribor, Faculty of Health Sciences
🇸🇮Maribor, Slovenia